FDA Approves Risperidone for Schizophrenia, Bipolar I Disorder

The FDA announced the approval of the extended-release injectable suspension risperidone (Rykindo; Luye Pharma Group) to treat adults with schizophrenia. Additionally, the FDA noted that the drug is also approved to be a monotherapy or adjunctive therapy (with lithium or valproate) for adults with bipolar I disorder.

“[Risperidone] is our first new drug developed in-house and approved for marketing in the [United States], demonstrating our long-standing commitment to serving patients around the world with innovative therapies," said Yang Rongbing, president of Luye Pharma Group, in a press release.

The treatment delivers risperidone using long-acting, extended-release microsphere technology. In effect, it only needs to be administered once every 2 weeks.

Prior to receiving FDA approval, researchers studied the antipsychotic in 3 clinical trials. The first trial was an open-label, single-ascending dose pharmacokinetic and safety study for patients with schizophrenia or schizoaffective disorder. The second trial looked at a 25 mg dose of risperidone in this patient population, and the third trial studied the effects of a single intramuscular injection at 25mg or 50mg in stable patients with schizophrenia and/or schizoaffective disorder.

Schizophrenia is a potentially severe and debilitating illness that results from disrupted thought processes, perceptions, emotional responsiveness, and social interactions. Symptoms may vary among patients, but they are usually persistent. The disease affects approximately 24 million people around the globe.

Bipolar disorder, estimated to affect 40 million people worldwide in 2019, is a category of mental illness divided into 3 classes: bipolar I, bipolar II, and cyclothymic disorder. Bipolar disorder is characterized by unusual shifts in mood, energy, activity levels, concentration, and the ability to do daily tasks, with bipolar I characterized by extreme manic and depressive episodes.

"Mental disorders including schizophrenia and bipolar disorder not only seriously affect the physical and mental health of patients, but also impose a heavy burden on their families and society,” Rongbing explains.

According to the results of the studies, in 5% or more of patients with schizophrenia, the most common adverse events (AEs) were headache, parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in the extremities, and dry mouth. Among patients with bipolar disorder, the most common AEs were weight increase (5%) and tremor and parkinsonism (10% or more).

In 2021, the new innovative treatment received market approval for patients with schizophrenia in China, and it is currently being developed in Europe. The company expects the drug to be available in more countries in the future.

Reference

Luye Pharma. FDA Approves Luye Pharma's Rykindo® for the Treatment of Schizophrenia and Bipolar 1 Disorder. News Release. January 15, 2023. Accessed on January 16, 2023. https://www.luyepharma.eu/en/